Status:
COMPLETED
Study of Self-Amplifying Messenger Ribonucleic Acid (samRNA) Vaccines Against COVID-19 in Healthy Adults and People Living With Human Immunodeficiency Virus (HIV)
Lead Sponsor:
Gritstone bio, Inc.
Conditions:
COVID-19
SARS-CoV-2
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The primary objective is to assess the safety and tolerability of samRNA vaccines GRT-R912, GRT-R914, and GRT-R918 when administered as prime and/or boost in healthy adult participants naïve to severe...
Detailed Description
This Phase 1 clinical trial (CORAL-CEPI) will assess the potential of second-generation Coronavirus Disease 2019 (COVID-19) vaccines. These vaccines use a codon optimized Spike (S) cassette with addit...
Eligibility Criteria
Inclusion
- Male or non-pregnant female at least 18 years and no more than 65 years of age at enrollment (Parts A, B, and C only).
- No previous SARS-CoV-2 infection or recovered.
- HIV-negative status confirmed by laboratory testing.
- Additional inclusion criteria for PLWH:
- Serum positive HIV test or history of HIV infection.
- On anti-retroviral therapy for at least 3 months before screening and clinically stable.
- Additional inclusion criteria for Part D (GRT-R918):
- Male or non-pregnant female between 18 and \<60 years of age at enrollment.
- Male or non-pregnant female greater than or equal to 60 years of age at enrollment.
- Received any authorized SARS-CoV-2 vaccine series at least 2 months prior to study vaccine.
Exclusion
- Current active infection with COVID-19.
- Positive for SARS-CoV-2 by nasal swab polymerase chain reaction (PCR) at screening.
- Currently receiving treatment or prevention agents with activity against SARS-CoV-2.
- Breastfeeding, pregnant, or planning to become pregnant during the course of the study.
- Received or plans to receive any non-study provided SARS-CoV-2 vaccine (including boost) during the study period (except for Part D).
- Received or plans to receive any live, attenuated vaccine within 28 days before or after study vaccination.
- Received or plans to receive any subunit or killed vaccine within 14 days before or after vaccination.
- Received or plans to receive immunoglobulins and/or any blood products within the 3 months preceding the planned administration of first study vaccination or at any time during the study.
- Currently active viral infection of hepatitis B virus or hepatitis C virus.
- Additional exclusion criteria for PLWH:
- Screening CD4+ T cell count ≤200 cells/mcL.
- Viral load ≥10,000 virus particles/mL.
- History of opportunistic illness indicative of Stage 3 HIV infection.
- Acute febrile illness within 4 weeks before the first vaccination.
- Additional exclusion criterion for Part D (GRT-R918) Cohorts D3, D4, D7, and D8:
- \- Received last dose of any authorized SARS-CoV-2 vaccine series within 2 months prior to study vaccine.
Key Trial Info
Start Date :
February 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2024
Estimated Enrollment :
342 Patients enrolled
Trial Details
Trial ID
NCT05435027
Start Date
February 28 2022
End Date
March 6 2024
Last Update
March 12 2024
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Newtown Clinical Research Centre
Johannesburg, South Africa
2
WITS RHI Shandukani Research Centre
Johannesburg, South Africa
3
Wits Vaccines & Infections Diseases Analytics (VIDA) Research Unit
Johannesburg, South Africa
4
Setshaba Research Center
Pretoria, South Africa